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Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

Primary Purpose

Child, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mask ventilation
Rocuronium
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Child

Eligibility Criteria

1 Month - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pediatric patients scheduled for elective surgery under general anesthesia
  • BMI < 30
  • ASA class 1 or 2

Exclusion Criteria:

  • with difficult airway
  • preexisting pulmonary disease
  • upper respiratory tract infection
  • intestinal obstruction
  • with risk of pulmonary aspiration
  • history of stoke or moyamoya disease

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromuscular blocker

Non-neuromuscular blocker

Arm Description

During induction of anesthesia, mask ventilation by pressure controlled ventilation is performed with after rocuronium administration in children while continuous gastric auscultation and abdominal sonography are performed.

During induction of anesthesia, mask ventilation by pressure controlled ventilation is performed without rocuronium in children while continuous gastric auscultation and abdominal sonography are performed.

Outcomes

Primary Outcome Measures

Inspiratory Pressure That Cause Gastric Insufflation
Difference in the inspiratory pressure that minimized the incidence of gastric insufflation, yet guaranteed a tidal volume of at least 6 ml/kg between the neuromuscular blocker and non-neuromuscular blocker groups. Gastric insufflation was measured using both gastric ultrasonography and epigastric auscultation.

Secondary Outcome Measures

Diagnostic Method That Detects Gastric Insufflation First

Full Information

First Posted
June 6, 2015
Last Updated
August 20, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02471521
Brief Title
Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children
Official Title
Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children: Study Using Detection of Gastric Insufflation Using Ultrasonography of the Antrum and Epigastric Auscultation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients. The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas. For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.
Detailed Description
The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients. The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. Stratum was constructed based on age and randomization scheme was performed separately within each stratum. Block randomization was done to ensure balance of the age groups. For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas. For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed. Tidal volume and oxygen saturation are recorded during study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Anesthesia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular blocker
Arm Type
Experimental
Arm Description
During induction of anesthesia, mask ventilation by pressure controlled ventilation is performed with after rocuronium administration in children while continuous gastric auscultation and abdominal sonography are performed.
Arm Title
Non-neuromuscular blocker
Arm Type
Active Comparator
Arm Description
During induction of anesthesia, mask ventilation by pressure controlled ventilation is performed without rocuronium in children while continuous gastric auscultation and abdominal sonography are performed.
Intervention Type
Other
Intervention Name(s)
Mask ventilation
Intervention Description
Mask ventilation is performed after administration of rocuronium or not. Initial inspiratory pressure is set as 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
Rocuronium 0.6 mg/kg is injected before mask ventilation in muscle relaxant group or after finish of study in non-relaxant group.
Primary Outcome Measure Information:
Title
Inspiratory Pressure That Cause Gastric Insufflation
Description
Difference in the inspiratory pressure that minimized the incidence of gastric insufflation, yet guaranteed a tidal volume of at least 6 ml/kg between the neuromuscular blocker and non-neuromuscular blocker groups. Gastric insufflation was measured using both gastric ultrasonography and epigastric auscultation.
Time Frame
Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
Secondary Outcome Measure Information:
Title
Diagnostic Method That Detects Gastric Insufflation First
Time Frame
Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pediatric patients scheduled for elective surgery under general anesthesia BMI < 30 ASA class 1 or 2 Exclusion Criteria: with difficult airway preexisting pulmonary disease upper respiratory tract infection intestinal obstruction with risk of pulmonary aspiration history of stoke or moyamoya disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD. PhD.
Organizational Affiliation
Seoul National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29998359
Citation
Lee JH, Jung H, Kim EH, Song IK, Kim HS, Kim JT. Optimal inspiratory pressure for face mask ventilation in paralyzed and unparalyzed children to prevent gastric insufflation: a prospective, randomized, non-blinded study. Can J Anaesth. 2018 Dec;65(12):1288-1295. doi: 10.1007/s12630-018-1183-2. Epub 2018 Jul 11.
Results Reference
derived

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Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

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